Drug Product Labeling Guidelines ASEAN
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Questions and Answers

What is the primary objective of the Administrative Order mentioned?

  • To ban certain herbal medicines
  • To enhance pharmaceutical sales
  • To rationalize labeling requirements (correct)
  • To increase drug prices

    • The Administrative Order applies only to manufacturers of conventional drug products.

    False

    What does API stand for?

    Active Pharmaceutical Ingredient

    An __________ is responsible for the physiological action of a drug substance.

    <p>Active Moiety</p> Signup and view all the answers

    Match the following terms with their definitions:

    <p>Active Moiety = Responsible for drug's action API = Therapeutically active ingredient Herbal medicines = Drug products derived from plants Administrative Order = Regulatory guideline for drug labeling</p> Signup and view all the answers

    Which entity is NOT included under the scope of the Administrative Order?

    <p>Retail customers</p> Signup and view all the answers

    The Administrative Order can apply to traditionally-used herbal products.

    <p>True</p> Signup and view all the answers

    What does the term 'noncovalent derivative' refer to?

    <p>Molecule forms like complex, chelate, or clathrate</p> Signup and view all the answers

    What indicates the name of an API for herbal medicines?

    <p>INN or official Philippine Pharmacopoeia name</p> Signup and view all the answers

    The percentage of alcohol in a product must be specifically indicated.

    <p>True</p> Signup and view all the answers

    What is the equivalent amount of elemental calcium in Calcium Carbonate listed as 750 mg?

    <p>300 mg</p> Signup and view all the answers

    The coloring agents used in pharmaceuticals must be indicated, particularly if they may cause __________.

    <p>hypersensitivity</p> Signup and view all the answers

    Match the following drugs with their correct indications:

    <p>Sodium Ascorbate = Vitamin supplement Amoxicillin = Antibiotic Omeprazole = Acid reducer Sulfamethoxazole = Antimicrobial</p> Signup and view all the answers

    Which monograph reference indicates the analysis method for a finished drug product?

    <p>USP, BP, EP, JP, PP, Ph.Int</p> Signup and view all the answers

    The labeling materials can include non-FDA approved uses of the drug product.

    <p>False</p> Signup and view all the answers

    The API of a drug product must be indicated followed by its corresponding __________.

    <p>reference monograph</p> Signup and view all the answers

    What does 'Date of Manufacture' refer to?

    <p>The date when processing is completed</p> Signup and view all the answers

    Dosage strength only refers to the quantity of active pharmaceutical ingredient (API) in the formulation.

    <p>False</p> Signup and view all the answers

    What is a dosage form?

    <p>The type of drug product, such as tablet, capsule, or cream.</p> Signup and view all the answers

    The _____ describes the quantity of medicine given per administration.

    <p>dosage</p> Signup and view all the answers

    Match the following terms with their definitions:

    <p>Dosage = The quantity of a medicine given per administration Drug Product = Any article recognized in official pharmacopoeias Dosage Form = Type of drug product, e.g., tablet or cream Dosage Strength = Refers to the concentration or potency of an API</p> Signup and view all the answers

    Which of the following is NOT considered a drug product?

    <p>Food intended for nutrition</p> Signup and view all the answers

    Herbal drugs are excluded from the definition of drug products.

    <p>False</p> Signup and view all the answers

    Name one pharmacopoeia recognized by the FDA.

    <p>United States Pharmacopoeia (USP)</p> Signup and view all the answers

    What does a prodrug require to exert its pharmacological effects?

    <p>It must be activated by metabolic transformation</p> Signup and view all the answers

    Prescription drug products can be dispensed without a physician's order.

    <p>False</p> Signup and view all the answers

    What is the purpose of precautions when using a drug product?

    <p>To avoid undesired effects and ensure safe and effective use.</p> Signup and view all the answers

    The ___ of a drug product refers to its name as registered in the FDA.

    <p>Product Name</p> Signup and view all the answers

    Match the following terms with their definitions:

    <p>Precautions = Instructions for safe drug use Registration Number = Proof of drug product registration by FDA Summary of Product Characteristics = Approved product information for health personnel Product Description = Complete organoleptic description of the drug</p> Signup and view all the answers

    Which of the following best defines 'small containers' in drug packaging?

    <p>Containers holding 5 mL or less</p> Signup and view all the answers

    The storage conditions of a drug product do not affect its stability.

    <p>False</p> Signup and view all the answers

    What are examples of small containers in drug packaging?

    <p>Ampoules, vials, jars, tubes.</p> Signup and view all the answers

    What should a drug label include regarding dosage information?

    <p>All recommended dosage details</p> Signup and view all the answers

    A drug label must include directions for special populations, such as adults and children.

    <p>True</p> Signup and view all the answers

    What should a label state if a drug is not recommended for children?

    <p>Adult dose</p> Signup and view all the answers

    The label shall include signs and symptoms of __________.

    <p>overdose</p> Signup and view all the answers

    Which of the following must be included on a drug label as a precaution?

    <p>For external use only</p> Signup and view all the answers

    Match the interaction type with its description:

    <p>Drug-drug = Interactions between two or more drugs Drug-food = Effects of food on drug efficacy Drug-laboratory testing = Influence of drugs on test results Drug-environmental = Interactions with environmental factors</p> Signup and view all the answers

    The label should include only positive effects of the drug.

    <p>False</p> Signup and view all the answers

    What additional information should be included on the label concerning adverse drug reactions?

    <p>Arranged by system organ class</p> Signup and view all the answers

    Study Notes

    Objective

    • Aim to harmonize generic labeling rules and regulations for drug products in line with ASEAN Member States.
    • Provides updated guidelines for manufacturers and distributors.

    Scope

    • Applies to all drug product manufacturers and distributors, including herbal medicines and traditional herbal products for human use.

    Definition of Terms

    • Active Moiety: The molecule responsible for the drug's physiological action, excluding certain noncovalent derivatives.
    • Active Pharmaceutical Ingredient (API): The active compound used in pharmaceutical product manufacturing.
    • Dosage: The amount of medication given per administration.
    • Dosage Form: The type of drug presentation (e.g., tablet, capsule, cream).
    • Dosage Strength: Typically refers to API concentration or potency expressed according to recognized pharmacopoeia standards.

    Drug Product Classification

    • Recognized by various pharmacopoeias (e.g., USP, BP, EP).
    • Intended for diagnosis, treatment, or prevention of diseases.
    • Includes herbal/traditional drugs recognized in the Philippine National Drug Formulary.

    Labeling Requirements

    • Product Name: Generic and brand names as registered with FDA.
    • Summary of Ingredients: Must list active ingredients with their respective amounts, followed by the relevant monograph reference.
    • Indications: Only FDA-approved clinical uses can be stated.

    Precautions and Warnings

    • Label must include precautions for safe use and avoid adverse effects.
    • Specific warnings required by FDA, such as "flammable" or "for external use only."

    Dosage and Administration

    • Comprehensive information on recommended dosages, frequency, adjustments, and special considerations for children or specific populations.

    Interactions

    • Label must disclose potential drug-drug, drug-food, and drug-laboratory interactions.

    Adverse Drug Reactions

    • Detailed information about possible adverse effects classified by organ system must be included on the label.

    Overdose Information

    • Signs and symptoms of overdose, as well as recommended treatment measures, should be clearly stated on the label.

    Storage Conditions

    • Clear specifications for the storage environment needed to maintain drug stability based on laboratory data.

    Small Containers Definition

    • Small containers defined as holding ≤5 mL or 5 g, including various types of vials, jars, and tubes.

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    Related Documents

    Drug Labelling Administrative Order No. 2016-0008 PDF

    Description

    This quiz will test your knowledge on the harmonization of drug product labeling rules and regulations among ASEAN Member States. You will learn about key definitions, classifications, and the scope of these guidelines for manufacturers and distributors. Perfect for anyone involved in the pharmaceutical industry.

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